Phase 4
N=144
A Comparison of Dexmedetomidine Versus Propofol for Use in Intravenous Sedation
Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT03255824 ↗Enrolled (actual)
144
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Respiratory Events Requiring Intervention — 17; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexmedetomidine and Midazolam (Drug); Propofol, Midazolam, and Fentanyl (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Respiratory Events Requiring Intervention |
17; 2 | — |
| SECONDARY Reaction to Administration of Local Anesthesia |
3.9; 4.2 | — |
| SECONDARY Patient Satisfaction |
93.5; 86.6 | — |
| SECONDARY Surgeon Satisfaction - Survey |
2.8; 2.9 | — |
| SECONDARY Cooperation Scale |
2.07; 1.47 | — |
| SECONDARY Hemodynamic Stability - Heart Rate |
77; 62 | — |
| SECONDARY Hemodynamic Stability - Blood Pressure |
78; 88 | — |
| SECONDARY Respiratory Depression - Respiratory Rate |
18; 18 | — |
| SECONDARY Respiratory Depression - Oxygen Saturation |
98.7; 98.9 | — |
| SECONDARY Postoperative Recovery Time - Duration of Procedure |
24.2; 22.1 | — |
| SECONDARY Postoperative Recovery Time - Ambulation |
10.8; 11.6 | — |
| SECONDARY Postoperative Recovery Time - Time to Discharge |
26.5; 29.9 | — |
Summary
Hypothesis: A combination of midazolam with dexmedetomidine for sedation during third molar surgery will provide 1) superior patient satisfaction, 2) superior operator satisfaction and 3) no significant hemodynamic or respiratory changes when compared to a sedation combination of midazolam, fentanyl and propofol for sedation during third molar surgery.
Eligibility Criteria
Inclusion Criteria
- Subject must have 3-4 partial or full bony impacted third molars requiring surgical extraction
- ASA Class I or II
- English-speaking and Spanish-speaking subjects
Exclusion Criteria
- ASA Class III or higher
- Patients taking alpha-2 agonists or benzodiazepines
- Allergy or drug reaction to any of the drugs used in this study (benzodiazepines, opioids, propofol, alpha-2 agonists, NSAIDs, local anesthetic)
- BMI greater than 30
- History of or current substance abuse or alcoholism
- History of mood-altering medications, tranquilizers, or antidepressants.
- Pregnant females
Data sourced from ClinicalTrials.gov (NCT03255824). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.